Tests

Standards

Identification

A. Infrared Absorption

B. Chromatographic Identity

Assay (on the anhydrous basis)

97.0%-103.0%

Residue on Ignition

≤0.1%

Ethylene Oxide

≤1ug/g

Dioxane

≤10ug/g

Ethylene Glycol

≤0.062%

Diethylene Glycol+Ethylene Glycol

≤0.2%

Formaldehyde

≤15ug/g

Formaldehyde + Acetaldehyde

≤200ug/g

Average Molecular Weight

3015-3685g/mol

Polydispersity

90%-110%

Hydroxyl Value

30-38

Acidity and Alkalinity

4.5-7.5

Water Determination

≤1.0%

Conclusion

The sample meets the requirements of USP-40